Clinical trial · Interventional
A Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Locally Recurrent or Metastatic Breast Cancer
A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Breast Cancer
NCT01973309CI-TRIAL-00047047completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with paclitaxel.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vantictumab combined with paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vantictumab combined with paclitaxel
- description
- Drug: vantictumab combined with paclitaxel - administered intravenously
- interventionNames
- Drug: Vantictumab combined with paclitaxel
Primary outcomes (1)
- measure
- Safety and tolerability of vantictumab in combination with paclitaxel in patients with locally recurrent or metastatic breast cancer
- timeFrame
- Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28 days).
- description
- The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with paclitaxel
Secondary outcomes (1)
- measure
- Pharmacokinetics (PK) of vantictumab when administered in combination with paclitaxel to patients with locally recurrent or metastatic breast cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Signed Informed Consent Form * Age ≥18 years * Histologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease o Patients with breast cancer overexpressing HER2 are not eligible. * Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * All acute treatment-related toxicity from prior therapy must have resolved to Grade ≤ 1 prior to study entry * Adequate hematologic and end-organ function * Evaluable or measurable disease per RECIST v1.1 * For women of childbearing potential, agreement to use two effective forms of contraception Exclusion Criteria: * Known significant dose delays during prior treatment with a taxane due to drug-related toxicities * Prior treatment with more than two regimens of systemic cytotoxic chemotherapy for locally recurrent or metastatic disease * Treatment with any anti-cancer therapy within 3 weeks prior to initiation of study treatment
References
Publications (1)
- DERIVEDDiamond JR, Becerra C, Richards D, Mita A, Osborne C, O'Shaughnessy J, Zhang C, Henner R, Kapoun AM, Xu L, Stagg B, Uttamsingh S, Brachmann RK, Farooki A, Mita M. Phase Ib clinical trial of the anti-frizzled antibody vantictumab (OMP-18R5) plus paclitaxel in patients with locally advanced or metastatic HER2-negative breast cancer. Breast Cancer Res Treat. 2020 Nov;184(1):53-62. doi: 10.1007/s10549-020-05817-w. Epub 2020 Aug 14. PMID 32803633